US2005154537A1PendingUtilityA1

Methods, program products, and systems for single and multi-agent dosing and other related methods

Priority: Dec 12, 2003Filed: Dec 10, 2004Published: Jul 14, 2005

Est. expiryDec 12, 2023(expired)· nominal 20-yr term from priority

Inventors:John D. Kutzko Michaeal G. Singer

A61K 49/0004G16H 20/10G16H 70/40

PatentIndex Score

Cited by

References

Claims

Abstract

Methods, program product, and systems for single and multi-agent dosing are provided. An embodiment of a method for revising a cycle dose of at least one agent for a patient receiving a single or multi-agent therapy includes accepting as a first input the patient's cycle dose(s) of the at least one agent, accepting as a second input determination of the relevancy of at least one surrogate marker indicating a pharmacologic response of the patient and determining a revised dose of the at least one agent. Embodiments of systems and program products are also provided for use in calculating revised dose of at least one agent.

Claims

exact text as granted — not AI-modified

1 . A method for revising a cycle dose of at least one agent in a therapy for a patient receiving such a therapy, the method comprising the steps of: 
 accepting as a first input the patient&#39;s cycle dose of the at least one agent;    accepting as a second input determination of the relevancy of at least one surrogate marker indicating a pharmacologic response of the patient; and    determining a revised cycle dose of the at least one agent as a function of the first input cycle dose and second input determination of the relevancy of the at least one surrogate marker.    
     
     
         2 . A method as defined in  claim 1 , wherein the cycle dose comprises a total amount of the at least one agent over a selected period of time.  
     
     
         3 . A method as defined in  claim 1 , wherein the therapy includes a single and multi-agent therapy.  
     
     
         4 . A method as defined in  claim 1 , further comprising the steps of: 
 accepting as a third input at least one non-pharmacologic modality the patient may be receiving; and    accepting as a fourth input determination of the relevancy of the at least one non-pharmacologic modality indicating achievement of a benefit.    
     
     
         5 . A method as defined in  claim 4 , wherein the revised cycle dose of the at least one agent is a function of the first input cycle dose, the at least one non-pharmacologic modality, determination of the relevancy of the at least one surrogate marker and determination of the relevancy of the at least one non-pharmacologic modality.  
     
     
         6 . A method as defined in  claim 1 , wherein two or more surrogate markers are analyzed concurrently.  
     
     
         7 . A method for revising a cycle dose of at least one agent in a therapy for a patient receiving such a therapy, the method comprising the steps of: 
 accepting as a first input the patient&#39;s cycle dose of the at least one agent;    accepting as a second input at least one non-pharmacologic modality received by the patient;    accepting as a third input determination of the relevancy of at least one surrogate marker indicating a pharmacologic response of the patient;    accepting as a fourth input determination of the relevancy of the at least one non-pharmacologic modality indicating achievement of maximum benefit; and    determining a revised cycle dose of the at least one agent responsive to the cumulative effect of the at least one agent and the at least one non-pharmacologic modality to be achieved by the therapy and non-pharmacologic intervention, the revised cycle dose being a function of the first input cycle dose, the at least one non-pharmacologic modality, determination of the relevancy of the at least one surrogate marker and determination of the relevancy of the at least one non-pharmacologic modality.    
     
     
         8 . A method as defined in  claim 7 , wherein two or more surrogate markers are analyzed concurrently.  
     
     
         9 . A system to calculate a revised cycle dose of at least one agent in a therapy for a patient receiving such a therapy, the system comprising: 
 means for accepting as a first input the patient&#39;s cycle dose of the at least one agent;    means for accepting as a second input determination of the relevancy of at least one surrogate marker indicating a pharmacologic response of the patient; and    means responsive to the first input and second input for calculating a revised cycle dose of the at least one agent.    
     
     
         10 . A system as defined in  claim 9 , further comprising: 
 means for accepting as a third input at least one non-pharmacologic modality received by the patient; and    means for accepting as a fourth input determination of the relevancy of the at least one non-pharmacologic modality indicating achievement of a benefit.    
     
     
         11 . A system as defined in  claim 10 , wherein the revised cycle dose of the at least one agent is a function of the first input cycle dose, the at least one non-pharmacologic modality, determination of the relevancy of the at least one surrogate marker and determination of the relevancy of the at least one non-pharmacologic modality.  
     
     
         12 . A system as defined in  claim 11 , wherein two or more surrogate markers are analyzed concurrently.  
     
     
         13 . A system to calculate a revised cycle dose of at least one agent in a therapy for a patient receiving such a therapy, the system comprising: 
 means for accepting as a first input the patient&#39;s cycle dose of the at least one agent;    means for accepting as a second input at least one non-pharmacologic modality received by the patient;    means for accepting as a third input determination of the relevancy of at least one surrogate marker indicating a pharmacologic response of the patient;    means for accepting as a fourth input determination of the relevancy of the at least one non-pharmacologic modality indicating achievement of maximum benefit; and    means responsive to the first, second, third and fourth inputs for calculating a revised cycle dose of the at least one agent as a function of the first input cycle dose, the at least one non-pharmacologic modality, determination of the relevancy of the at least one surrogate marker and determination of the relevancy of the at least one non-pharmacologic modality.    
     
     
         14 . A system as defined in  claim 13 , wherein two or more surrogate markers are analyzed concurrently.  
     
     
         15 . A program product stored on a tangible computer memory medium to calculate a revised cycle dose of at least one agent in a therapy for a patient receiving such a therapy, the program product comprising: 
 means for accepting as a first input the patient&#39;s cycle dose of the at least one agent;    means for accepting as a second input determination of the relevancy of at least one surrogate marker indicating a pharmacologic response of the patient; and    means responsive to the effect of the at least one agent to be achieved by the therapy for calculating a revised cycle dose of the at least one agent as a function of the first input cycle dose and second input determination of the relevancy of the at least one surrogate marker.    
     
     
         16 . A program product as defined in  claim 15 , wherein two or more surrogate markers are analyzed concurrently.  
     
     
         17 . A program product stored on a tangible computer memory medium to calculate a revised cycle dose of at least one agent in a therapy for a patient receiving such a therapy, the program product comprising: 
 means for accepting as a first input the patient&#39;s cycle dose of the at least one agent;    means for accepting as a second input at least one non-pharmacologic modality received by the patient;    means for accepting as a third input determination of the relevancy of at least one surrogate marker indicating a pharmacologic response of the patient;    means for accepting as a fourth input determination of the relevancy of the at least one non-pharmacologic modality indicating achievement of maximum benefit; and    means responsive to the cumulative effect of the at least one agent and the at least one non-pharmacologic modality to be achieved by the therapy and non-pharmacologic intervention for calculating a revised cycle dose of the at least one agent as a function of the first input cycle dose(s), the at least one non-pharmacologic modality, determination of the relevancy of the at least one surrogate marker and determination of the relevancy of the at least one non-pharmacologic modality.    
     
     
         18 . A program product as defined in  claim 17 , wherein two or more surrogate markers are analyzed concurrently.  
     
     
         19 . A program product stored on a tangible computer memory medium to calculate a revised cycle dose of at least one agent in a therapy for a patient receiving such a therapy, the program product comprising: 
 a first receiver to accept as a first input the patient&#39;s cycle dose(s) of the at least one agent;    a second receiver to accept as a second input determination of the relevancy of at least one surrogate marker indicating a pharmacologic response of the patient; and    a calculator to calculate a revised cycle dose of the at least one agent as a function of the first input cycle dose and second input determination of the relevancy of the at least one surrogate marker in response to the effect of the at least one agent to be achieved by the therapy.    
     
     
         20 . A program product as defined in  claim 19 , wherein two or more surrogate markers are analyzed concurrently.  
     
     
         21 . A program product stored on a tangible computer memory medium to calculate a revised cycle dose of at least one agent in a therapy for a patient receiving such a therapy, the program product comprising: 
 a first receiver to accept as a first input the patient&#39;s cycle dose of the at least one agent;    a second receiver to accept as a second input at least one non-pharmacologic modality received by the patient;    a third receiver to accept as a third input determination of the relevancy of at least one surrogate marker indicating a pharmacologic response of the patient;    a fourth receiver to accept as a fourth input determination of the relevancy of the at least one non-pharmacologic modality indicating achievement of maximum benefit; and    a calculator to calculate a revised cycle dose of the at least one agent as a function of the first input cycle dose, the at least one non-pharmacologic modality, determination of the relevancy of the at least one surrogate marker and determination of the relevancy of the at least one non-pharmacologic modality in response to the cumulative effect of the at least one agent and the at least one non-pharmacologic modality to be achieved by the therapy and non-pharmacologic intervention.    
     
     
         22 . A program product as defined in  claim 21 , wherein two or more surrogate markers are analyzed concurrently.

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